AssurX’s picture

By: AssurX

Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top concern.

Scott Gottlieb’s picture

By: Scott Gottlieb

It is incumbent upon the U.S. Food and Drug Administration (FDA) to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies. By taking an efficient, risk-based approach to our regulation, the FDA can promote health through the creation of more new and beneficial medical technologies.

InfinityQS’s picture

By: InfinityQS

On Jan. 1, 2017, Philadelphia became one of the first U.S. cities to pass a tax ($0.15 per oz) on sugary drinks, including artificially sweetened beverages, such as diet soda. In California, San Francisco, Albany, Berkeley, and Oakland have joined Philadelphia in this initiative, as well as Boulder, Colorado; Cook County, Illinois; and Seattle.

Claire McCluskie’s picture

By: Claire McCluskie

With ISO 13485:2016—“Medical devices—Quality management systems—Requirements for regulatory purposes” published and being implemented, many medical device customers are experiencing some uncertainty about the effect that one of the standard’s key changes might have on their business: computer software validation.

Amie Whittington’s picture

By: Amie Whittington

Is your governmental hospital exempt under Section 501(c)3? If you have a 403(b) plan, the answer is yes, but even if you don’t, you need to check.

The Internal Revenue Service (IRS) is ramping up compliance audits of governmental hospitals that are exempt under 501(c)3 (dual status). The circumstances leading up to now are important because the implications can be difficult to understand.

Ian Haydon’s picture

By: Ian Haydon

There’s a revolution happening in biology, and its name is CRISPR. CRISPR (pronounced “crisper”) is a powerful technique for editing DNA. It has received an enormous amount of attention in the scientific and popular press, largely based on the promise of what this powerful gene-editing technology will someday do.

Erin Connelly’s picture

By: Erin Connelly

For a long time, medieval medicine has been dismissed as irrelevant. This time period is popularly referred to as the “Dark Ages,” which erroneously suggests that it was unenlightened by science or reason. However, some medievalists and scientists are now looking back to history for clues to inform the search for new antibiotics. The Conversation

AssurX’s picture

By: AssurX

The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on real-world evidence (RWE).

AssurX’s picture

By: AssurX

The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.

Rob Mitchum’s picture

By: Rob Mitchum

People have touted the potential of big data and computation in medicine for what feels like decades, promising more effective and personalized treatments, new research discoveries, and smarter clinical predictions. But only recently have these technologies made it to the clinic, where they can actually improve patient care.

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